Annuloplasty ring holder

ABSTRACT

An annuloplasty ring holder including a head having an upper surface and an annuloplasty ring receiving surface facing opposite the upper surface. The annuloplasty ring holder also includes means for attaching an annuloplasty ring to the annuloplasty ring receiving surface. The means for attaching an annuloplasty ring to the annuloplasty ring receiving surface may include one or more suture guides operatively associated with the head and configured to position one or more sutures to removably associate an annuloplasty ring with the annuloplasty ring receiving surface. The head may include a central hub and more than one spoke radiating out from the central hub. If the head is thus configured, each spoke will include a portion of the annuloplasty ring receiving surface.

RELATED APPLICATIONS

This application is a Continuation of U.S. patent application Ser. No.12/721,019, filed Mar. 10, 2010, now U.S. Pat. No. 8,163,009, issuedApr. 24, 2012; which is a Continuation of U.S. patent application Ser.No. 11/534,188 filed Sep. 21, 2006, now U.S. Pat. No. 7,691,143, issuedApr. 6, 2010, which claims priority from U.S. Provisional PatentApplication Ser. No. 60/719,483, filed Sep. 21, 2005, entitledAnnuloplasty Ring Holder.

TECHNICAL FIELD

The present invention is directed toward an annuloplasty ring holder andmore particularly toward an annuloplasty ring holder with anannuloplasty ring receiving surface facing opposite an upper surface.

BACKGROUND ART

Annuloplasty rings are used to stabilize and restrict the mitral ortricuspid annulus in heart valve repair surgery. There are severaldifferent types of annuloplasty rings in current clinical use. Forexample, the Carpentier-Edwards ring is a rigid “D” shaped semi-closedring. The Cosgrove-Edwards band is a fully flexible “C” shaped ring, andthe Medtronic-Duran ring is a fully flexible circular ring.

Annuloplasty ring holders are particularly useful for use duringimplantation of flexible annuloplasty rings because of certain surgicalattachment and positioning challenges caused by the very nature of therings' flexibility. Without a holder, the surgical assistant has toretain the ring using his or her fingers, or using a pair of forceps.This is awkward as the ring holding point has to be frequentlyreadjusted as the several implantation sutures are placed through thecircumference of the ring body. For this reason, many surgeons preferthat flexible annuloplasty rings be supplied mounted on disposableholders.

An annuloplasty ring is often secured to the holder using one or moresutures that may pass through the body of the ring or around a ringsection. The ring is released from the holder by severing one or more ofthe retaining sutures.

Prior art annuloplasty ring holders feature a circumferential channel orflange against which the annuloplasty ring may be secured. Typicallyholders are substantially planar. Thus, with prior art devices theannuloplasty ring is positioned around the outer circumference of theplanar holder structure. This configuration can in certain instanceslimit a surgeon's ability to securely abut an annuloplasty ring againsta patient's annulus since the holder may interfere with properpositioning. In addition, prior art annuloplasty ring holders typicallyfeature a holder head having a curved or shaped circumferential channelor flange which supports the ring along some or all of its innercircumference. Such devices excel at holding an annuloplasty ring in adesired shape. However the extended ring contact along a shapedcircumferential supporting surface or channel can limit a surgeon'sability to effectively place attachment sutures through the ring. Inparticular, an extended ring contact surface prohibits a surgeon fromusing running sutures. Circumferential ring placement on a holder canalso hinders efficient ring release after implantation. The presentinvention addresses one or more of these concerns.

SUMMARY OF THE INVENTION

The present invention is an annuloplasty ring holder including a headhaving an upper surface and an annuloplasty ring receiving surfacefacing opposite the upper surface. The annuloplasty ring holder alsoincludes means for attaching an annuloplasty ring to the annuloplastyring receiving surface. The means for attaching an annuloplasty ring tothe annuloplasty ring receiving surface may include one or more sutureguides operatively associated with the head and configured to positionone or more sutures to removably associate an annuloplasty ring with theannuloplasty ring receiving surface.

The head of this embodiment may include a central hub and more than onespoke radiating out from the central hub. If the head is thusconfigured, each spoke will include a portion of the annuloplasty ringreceiving surface. In a hub and spoke embodiment the means for attachingan annuloplasty ring to the annuloplasty ring receiving surface of anygiven spoke may include at least one suture guide operatively associatedwith the spoke and configured to position a suture for the removableassociation of an annuloplasty ring with that portion of theannuloplasty ring receiving surface on the spoke. The suture guide mayinclude at least one hole passing through the select spoke between theupper surface and the portion of the annuloplasty ring receiving surfaceassociated with the spoke. The suture guide may also include a grooveoperatively associated with a distal end of the select spoke the groovedefining a channel for a suture to pass between the upper surface andthe annuloplasty ring receiving surface.

The annuloplasty ring holder of this embodiment may include any numberof spokes and the number and configuration of the spokes may be selectedto hold annuloplasty rings of various configurations. An annuloplastyring holder with five spokes may to be useful for supporting a partialor C-shaped flexible ring. Similarly an annuloplasty ring holder withsix spokes may be used to support a complete ring.

The annuloplasty ring holder may include a circumferential suturechannel around the hub and a handle extending from the upper surface.The handle may include a stem and an attachment member. In addition thehead may include a central hole defined by the hub and configured toreceive the attachment member, thus providing for a detachable handle.It is desirable that the stem be sufficiently malleable that it may bebent into a desired configuration in normal use. A particularly usefulstem may be made of a shape memory metal which may be heat set in aninitial straight or linear configuration prior to use, bent as desiredduring use, and which will return to the straight shape upon heatsterilization.

Another embodiment of the present invention is an annuloplasty ring andholder combination. The annuloplasty ring holder may be as is describedabove. In the combination embodiment an annuloplasty ring is removablyassociated with the annuloplasty ring receiving surface of the head.This embodiment may include a ring suture as the mechanism for removablyassociating the annuloplasty ring to the head. Preferably, a single ringsuture which is also securely attached to the head is used to secure thering. In addition, a retaining suture may be used to removably associatethe ring suture with the central hub. Preferably the retaining suture istied and configured such that severance of the retaining suture in oneplace will allow the ring suture to be fully released from the ring.

Another aspect of the present invention is a method of attaching anannuloplasty ring to an annuloplasty ring holder. The method includesproviding an annuloplasty ring holder as described above and removablyattaching an annuloplasty ring to the annuloplasty ring receivingsurface. The ring may be attached with a ring suture, and the ringsuture may be attached to the head with a retaining suture.

Another aspect of the present invention is a method of releasing anannuloplasty ring from an annuloplasty ring holder as described above.The method includes severing a retaining suture in a single place whichallows the full disassociation of a ring suture from an implantedannuloplasty ring.

Another aspect of the present invention is a method of implanting anannuloplasty ring. The implantation method includes providing anannuloplasty ring holder and ring as described above. According to theimplantation method a surgeon will place an implanting suture in theannulus of a patient and place the annuloplasty ring and holder near thepatient's chest. The implanting suture may then be passed through theannuloplasty ring and the annuloplasty ring and holder may be pusheddown the implanting suture so that the annuloplasty ring lies againstthe annulus. Implantation knots may then be tied in the implantationsuture. Subsequently the retaining suture may be severed releasing thering suture and allowing the removal of the ring suture from between theannuloplasty ring and annulus and subsequent removal of the annuloplastyring holder.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an isometric view of the holder with an annuloplasty ringattached. The holder handle and stem have been detached.

FIG. 2 is an isometric view of the holder with an annuloplasty ringattached. The releasable member at the base of the stem has beendetached from the holder.

FIG. 3 is a partial cross sectional view of the holder hub and stemattachment member taken along line A-A of FIG. 2.

FIG. 4 is a side elevation view of the holder with an annuloplasty ringattached. The releasable member at the base of the stem has beendetached from the holder.

FIG. 5 is a plan view of the holder and handle with an annuloplasty ringattached.

FIG. 6 is a phantom isometric view of the holder with an annuloplastyring attached. Suture paths are shown.

FIG. 7 is an isometric view of the holder with an annuloplasty ringattached, featuring orientation channels.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

FIG. 1 is an isometric view of an annuloplasty ring holder 10 with anannuloplasty ring 12 attached. Although shown in FIG. 1 with a head 14and a handle 16, the annuloplasty ring holder 10 of the presentinvention may be supplied as a head 14 only. Certain embodiments willinclude a handle 16, the invention is not however limited to suchembodiments.

FIG. 2 is an isometric view of a holder 10 consistent with the presentinvention. The head 14 includes an upper surface 18 and an annuloplastyring receiving surface 20 facing opposite the upper surface. The presentinvention is not limited to head 14 embodiments which are substantiallyplanar, however in a planar implementation the upper surface 18 facesthe handle 16 if a handle 16 is present. The annuloplasty ring receivingsurface 20 is opposite the upper surface 18 and faces away from thehandle 16. Positioned substantially between the upper surface 18 and theannuloplasty ring receiving surface 20 is a circumferential edge 22which may be of any thickness. Removable association of an annuloplastyring 12 with the annuloplasty ring receiving surface 20 of the presentinvention is a significant departure from prior art annuloplasty ringholders which rely upon the circumferential edge 22 to support the ring.The novel placement of an annuloplasty ring 11 against an annuloplastyring receiving surface 20 opposite the upper surface 18 and handle 16facilitates ring placement, provides for superior release of theannuloplasty ring from the holder after implantation and allows for theuse of an open spoke design as is discussed in detail below. Suchadvantages are difficult or impossible to achieve with prior artembodiments where a ring is mounted in a circumferential groove, againsta circumferential flange or otherwise associated with a circumferentialedge.

As is shown in FIG. 2 the head 14 may include a central hub 24 and morethan one spoke 26 radiating out from the central hub 24. In a spoke andhub embodiment each spoke 26 will include a portion of the annuloplastyring receiving surface. Spokes 26 may be configured to point at oridentify certain anatomical structures associated with a heart valve orannulus. Spokes also allow the use of running sutures if desired by thesurgeon. The embodiment shown in the figures features six spokes ofdissimilar length. A six spoke embodiment of the present invention issuitable for supporting a complete annuloplasty ring as shown in thefigures. The dissimilar length of the spokes 26 provides for the ring tobe held in a suitable shape when attached to the holder 10 forimplantation. An embodiment with five spokes may be used with a partialor “C” shaped flexible ring. Other embodiments with different numbers,lengths or configurations of spokes 26 will be readably apparent tothose skilled in the art.

The head 14 includes means for removably attaching an annuloplasty ringto the annuloplasty ring receiving surface 20. The means for attachmentcould be a mechanical structure, such as a clip or bracket or a chemicalbond or weld such as an easily broken glue joint. A preferred embodimentof the present invention however will include one or more suture guides28 associated with the head 14 and configured to position one or moresutures to removably associate an annuloplasty ring 12 with theannuloplasty ring receiving surface 20. As shown in FIG. 2 the sutureguide 28 may include at least one hole passing through the head 14,between the upper surface 18 and the annuloplasty ring receiving surface20. The suture guide 28 may also include a groove or other structureoperatively associated with a distal end of a spoke 26 defining achannel for a suture to pass between the upper surface 18 and theannuloplasty ring receiving surface 20.

Referring back to FIG. 1 it is shown that the holder handle 16, ifpresent, has a stem 30 which is preferably malleable, a grip 32 and twoopposing flats 34 (only one flat 34 is visible in FIG. 1). The flats 34may be used by the surgeon to properly orient the ring and holder 10during surgery. A groove 36 associated with the handle 16 is used toretain a suture 38 that may hold a serial number or other identificationidentity tag 40. A malleable stem 30 is preferable since a surgeon maydesire to bend the stem 30 in use for proper ring positioning.Similarly, a stem made of a shape memory alloy such as Nitinol or othernickel-titanium alloys is particularly advantageous. A shape memory stem30 may be heat set in a straight configuration, bent as needed by asurgeon during use, and restored to its original straight configurationby reheating during subsequent sterilization processes.

The distal end of the malleable stem 30 may include an attachment member42 that has two parallel leg members 44, 46 separated by slot 48. FIGS.3 and 4 show a detailed view of the attachment member 42 and associatedstructures. Stepped portions 50, 52 are terminated with chamferedflanges 54, 56. When parallel leg members 44, 46 are squeezed together(by forceps applied close to steps 50, 52), parallel legs 44, 46 bendinward sufficiently to allow flanges 54, 56 to be freely inserted into ahole 58 in the head 14. Preferably, the hole 58 is polygonal to assurethat the head 14 can not rotate with respect to the handle 16.

One embodiment of the suture guide 28 described generally above is shownin detail on FIG. 2 and FIG. 5, a plan view of the head 14. In thisembodiment, each spoke 26 contains an outer axial through hole 60, aninner axial through hole 62, and is terminated at its distal end by asmall axial groove 64. A select one of the spokes 26 includes anadditional inner axial through hole 66. The central hub 24 has acircumferential channel 68, best shown in FIG. 3, which is a partialcross section view of the hub 24 and attachment member 42 taken alongline A-A of FIG. 5. Hub 24 also has a radially placed recessed scalpelslot 70 that intersects the circumferential channel 68 to form aretaining suture cutting guide. Lower filleted wall 72 prevents ascalpel point from damaging the adjacent natural valve leaflet when aretaining suture 74 is cut as described below.

As is shown in FIGS. 2 and 6, a continuous single length of ring suturematerial 76 (possibly with its first end overlapping hole 66) is formedinto an appropriate number of loops corresponding to each spoke 26 byfollowing the sequence described herein. The loops collectively retainthe annuloplasty ring 12 to the head 14. It is important to note thatother loop or tying sequences for securing an annuloplasty ring 12 to aholder head 14 with a continuous single length of ring suture 76 will bereadily apparent to those skilled in the art, and are within the scopeof the present invention. In addition, an annuloplasty ring 12 may besecured to the holder head 14 with more than a single length of suturematerial.

The securing loops may be formed by passing the ring suture 76 throughthe holes 60, 62 and around the ring 12 as follows. The second end ofthe ring suture 76 is passed upward through hole 62 in a first selectspoke 26. The second end is then passed down through hole 60 of the samespoke 26 and partially wrapped around the medial, lower, and lateralquadrant sections of the annuloplasty ring 12. This end of the ringsuture 76 is then passed upward along the axial groove 64 of the selectspoke 26 to the upper surface 18. The second end of the ring suture 76is then passed along the upper surface 18 of the select spoke 26 to thehub channel 68. Within the hub channel 68, the ring suture 76 will bedoubled back. As is described in detail below, the ring suture 76 may beheld captive at the hub with the retaining suture 74. The doubling backof the ring suture 76 causes a hairpin bend 78 such that the ring suture76 is directed back along the upper surface 18 of the same spoke 26returning to axial groove 64.

The second end of the ring suture material 76 is then passed down alongaxial groove 64 and wrapped around the annuloplasty ring 12 a secondtime. After thus securing the annuloplasty ring 12 with a second wrapper spoke, the ring suture 76 is passed upward through hole 60, downthrough hole 62, and subsequently passed in a counterclockwise orclockwise manner to an adjacent spoke 26. At the adjacent spoke 26, theloop forming process is repeated until the annuloplasty ring 12 has beensecured to each spoke 26. Alternatively, the annuloplasty ring could besecured to only a select subset of all spokes.

The loop forming process is concluded when the second end of the ringsuture 76 is tied to the first end at or near hole 66. The knot 80formed between the first and second ends of the ring suture 76 is shownpositioned between holes 62 of adjacent spokes 26 in FIG. 2. This knot80 can be locate elsewhere at the discretion of the technician attachingan annuloplasty ring 12 to the head 14.

The hairpin bends 78 of the ring suture loops lie in circumferentialchannel 68, where they are retained by a retaining suture 74 that alsolies in channel 68. The ends of the retaining suture 74 are tied in aknot 82 adjacent to hole 66. One suture knot tail end is passed downwardthrough hole 66, is then passed upward on one side of the spoke 26, andtied to its other knot tail end. This second knot 84 may overlie knot 82or be separate as is shown in the figures. Variations in actual suturepaths and knot locations will be apparent to one skilled in the art. Themethod described above or alternative methods are suitable forimplementation of the present invention, provided that both sutures 74,76 are secured to the head 14 of the holder 10 and thus can not becomedetached from the holder 10 and thus potentially fall unnoticed into thepatient's chest cavity or heart chamber.

Release of the annuloplasty ring from the holder is accomplished byusing a scalpel in scalpel slot 70, hence severing the retaining suture74, which in turn releases hairpin loops 78. The holder may then begently removed from the ring. Hairpin loops 78 may be gently pulled frombetween the lower quadrants of the ring and the tissue of the annulus aspart of the removal process.

The use of the holder 10 may generally be described with particularreference to FIG. 3 (a partial cross sectional view of the holder hub 24and attachment member 42 taken along line A-A of FIG. 2), and FIG. 4.Parallel leg members 46, 44 are separated by slot 48. Stepped portions50, 52 are terminated with chamfered flanges 54, 56. When members 46, 44are squeezed together close to steps 50, 52, members 46, 44 bend inwardsufficiently to allow flanges 54, 56 to freely enter hole 58. Handleflats 34 indicate to the surgeon the orientation of the distal flatsurfaces of members 46, 44 to be compressed using artery forceps.

During implantation of the ring, double needle ended implanting suturesare first placed in the patient's heart valve annulus. The two needlesof each implanting suture are then passed through the annuloplasty ring12 approximately 3-4 mm apart, the ring being mounted onto the holderhead 14 with the handle 16 attached. At this time, the ring and holderare near the patient's chest but typically outside of the surgical zone.The implantation suture is partially pulled through the ring 12. Afterall the needles have been passed through the ring 12, the suture bundleis grasped with a pair of forceps and the needles are cut off thesutures. The malleable stem 30 is bent as required and the annuloplastyring 12 and holder 10 is pushed down the sutures so that the ring lieson and against the annulus. Mounting the ring 12 on the annuloplastyring receiving surface opposite the handle 16 facilitates properplacement. The handle 16 may then be removed by squeezing together legs44, 46 (close to steps 50, 52), thus releasing member 42 from hole 58.The handle 16 may then be withdrawn from the operative field to allowimproved access to the surgeon for the tying of the implantation knots.If required, the handle may be reinserted in hole 58 after squeezinglegs 44, 46 together once more. Finally, the head 14 may be releasedfrom the ring by severing retaining suture 74 at scalpel slot 70 andgently teasing loops 78 from under the annuloplasty ring at thering/tissue interface.

FIG. 7 is an illustration of alternative embodiment of the holder 10similar in overall design to that illustrated in FIG. 2. In the FIG. 7embodiment however, a series of orientation channels 86A-D are formed inthe hub 24. The orientation channels 86A-D are configured to mate withan orientation tab 88 associated with the attachment member 42. Theinclusion of an orientation tab 88 and orientation channels 86A-Dassures that the head 14 will be mounted to the handle 16 with theproper orientation, thus guaranteeing that the annuloplasty ringreceiving surface 20 is opposite the handle in use.

While the invention has been particularly shown and described withreference to a number of embodiments, it would be understood by thoseskilled in the art that changes in the form and details may be made tothe various embodiments disclosed herein without departing from thespirit and scope of the invention and that the various embodimentsdisclosed herein are not intended to act as limitations on the scope ofthe invention.

The invention claimed is:
 1. A method of releasing an annuloplasty ringfrom an annuloplasty ring holder comprising: providing an annuloplastyring holder; providing an annuloplasty ring removably attached to theannuloplasty ring holder with one or more sutures, wherein theannuloplasty ring is a partial or C-shaped ring; severing a singlesuture of the one or more sutures once and severing no other sutures ofthe one or more sutures; and disassociating the annuloplasty ring holderfrom the annuloplasty ring, wherein more than one suture is attached tothe annuloplasty ring holder before the step of severing only one sutureand all of said sutures remain attached to the annuloplasty ring holderafter disassociating the annuloplasty ring holder from the annuloplastyring.
 2. The method of releasing an annuloplasty ring from anannuloplasty ring holder of claim 1 further comprising simultaneouslywithdrawing the annuloplasty ring holder and the severed suture from theannuloplasty ring.
 3. The method of releasing an annuloplasty ring froman annuloplasty ring holder of claim 1 wherein the annuloplasty ring isremovably attached to the annuloplasty ring holder with a continuoussingle length of suture.
 4. A method of attaching an annuloplasty ringto an annuloplasty ring holder comprising: providing an annuloplastyring holder; providing an annuloplasty ring having a partial or c-shapedring; and attaching an annuloplasty ring to the annuloplasty ring holderwith one or more sutures such that the annuloplasty ring may be releasedfrom the annuloplasty ring holder by severing once a single suture ofthe one or more sutures, without severing any other suture of the one ormore sutures, wherein more than one suture is attached to theannuloplasty ring holder before the step of severing only one suture andall of said sutures remain attached to the annuloplasty ring holderafter disassociating the annuloplasty ring holder from the annuloplastyring.
 5. The method of attaching an annuloplasty ring to an annuloplastyring holder of claim 4 further comprising attaching each of the one ormore sutures to the annuloplasty ring holder.
 6. The method of attachingan annuloplasty ring to an annuloplasty ring holder of claim 5 furthercomprising attaching the annuloplasty ring to the annuloplasty ringholder with a continuous single length of suture.